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Medtronic study to assess laser ablation treatment for epilepsy
Medtronic has commenced a new clinical trial that will assess the benefits of MRI-guided laser ablation technology for the treatment of drug-resistant mesial temporal lobe epilepsy (MTLE).
The US Food and Drug Administration has approved an investigational device exemption application for the pivotal SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy) study, which is designed to support an expanded indication for its Visualase laser ablation technology.
It will include 120 adult patients with drug-resistant MTLE from across the US. Patients will be followed for 12 months after the Visualase procedure and evaluated for freedom from seizures, quality of life, adverse events and neuropsychological outcomes.
MTLE is the most common form of partial or localisation-related epilepsy. It is thought that laser ablation could represent a minimally-invasive treatment option for some patients.
Scott Hutton, vice-president and general manager of Medtronic's neurosurgery business, said: "Uncontrolled seizures lead to a wide variety of medical consequences and can have significant lifestyle and psychosocial impacts. We're hopeful that people with drug-resistant MTLE can benefit from our innovative Visualase technology."
Earlier this month, the company commenced another study assessing its new Valiant Evo thoracic stent graft system as a means of repairing descending thoracic aortic aneurysms.
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